Pharmacovigilance Courses in Pune

1
Pharmacovigilance planning and norms The approval
of any drug or product is based on the drug
having homeostasis between risks and benefits
within the specified conditions in the product
labeling. The basis of approval of the drug is
solely dependent on the information available
during the time of approval. The information
gathered about the safety characteristics and
number of patients exposed to the drug.
Especially during the early post-marketing
period, the drug shall be used in various
settings that are very different from clinical
trials. Much larger sample size will be exposed
to the drug in a relatively shorter time-frame.
Take Clinical Research Training.
As soon as the drug is marketed, new knowledge
with respect to the drug shall be uncovered,
which may or may not have an impact on the
balance between the risks and the benefits of the
drug. The analysis and evaluation of this newly
acquired knowledge should be a continuous
process with the regulatory authorities. This
evaluation is extremely detailed and is conducted
by pharmacovigilance processes to ensure the
safe use of the drug. Learn Pharmacovigilance
Course. Planning of pharmacovigilance on the
basis of the norms The entire pharmacovigilance
plan revolves around the safety specifications of
the drug. The plan is developed only after a
discussion with the regulators during product
development. The plan can be a stand-alone
document. However, it should have the essence of
the whole project. Drugs with no complications
generally undergo a routine pharmacovigilance
plan which must be sufficient for post-approval
safety monitoring without any form of additional
actions. Additional actions are designed to
address concerns like potential risks or missing
information for products with identified risks.
The length of this document depends on the
development and planning program of the drug.
This pharmacovigilance plan plays a vital role in
the development of the drug and should be
updated on a regular basis. This plan is updated
as important information on the safety of the
drug is discovered, and milestones are achieved.
Structure of the Pharmacovigilance Plan based on
the Norms. Take Clinical Research Training.
2

• Pharmacovigilance planning and norms
• The structure of a pharmacovigilance plan is the
  most basic outline. This plan is customized and
  modified based on the safety specifications and
  the issues identified with a particular drug.
• Routine pharmacovigilance procedures are
  conducted on all types of drugs. These are done
  irrespective of the additional procedures which
  are a part of the pharmacovigilance plan. This
  routine generally includes methods and systems
  that guarantee that information about all the
  suspected negative effects reported are initially
  collected and later collated in an efficient
  manner. Routine procedures also include the
  formation of reports for the regulatory
  authorities. Periodic safety update reports
  (PSUR) and expedited adverse drug reaction
  reports (ADR) are drawn up. Another vital part
  of this routine pharmacovigilant procedure
  involves the continuous monitoring of the safety
  profile of the drug. This includes signal
  detection, issue evaluation, updating of the
  labels, and liaison with the authorities. The
  local regulations determine the rest.
• A plan of action for the safety issues is
  presented and justified based on the objective of
  the proposed action of the drug. These include
  actions proposed by the drug itself, the
  rationale of these proposed actions caused by
  the drug, safety profile of the drug, monitoring
  of the drug based on the safety profile, the
  achieved milestones for evaluation and reporting
  of the drug.
• An overall plan for the drug bringing together
  the actions for all individual safety issues must
  be presented. It is practicable that milestones
  for the completion of the studies and other forms
  of analysis and the submission of safety results
  must be included in the Pharmacovigilance
  Training. On the path to achieving these
  milestones, the key points to be kept in mind
  include
• Results of the ongoing or proposed safety studies
  are to be available.
• The exposure to the drug would have reached a
  certain level of characterization based on the
  adverse effects of concern or resolving a
  particular issue.
• The regulatory milestones are generally aligned
  with these milestones. These are specifically
  used to revise or update the Pharmacovigilance
  plan.
• Pharmacovigilance Methods
• The most efficient method to address a specific
  situation is solely dependent on the drug in
  question. It also depends on the indication, the
  type of population being treated, and the issue
  that is being considered. The type of method also
  depends on the fact if the information is

3
Pharmacovigilance planning and norms missing, the
type of risk being considered, potential risks,
and if the signal detection, evaluation, or
safety demonstration is the main objective of the
studythe choice of the method in addressing
safety concerns the most appropriate design
should be employedthe key methods in
pharmacovigilance aid the professionals in
considering the design of the whole process. The
sponsors and regulatory authorities undergo
special and vigorous pharmacovigilance training
while pursuing pharmacovigilance courses in order
to conduct and develop these drugs with the most
optimal balance of risks and benefits. These drug
trials require clinical trials, thereby making
it obligatory for the sponsors to undergo
additional clinical research training based on
clinical research courses. The entirety of the
safety profile of the drugs is based on its
safety profile governed by the balance of the
risks and benefits. These need to adhere to the
strict procedure, which is solely mentored and
guided by the pharmacovigilance plan. This plan
needs to be updated on a regular basis to ensure
that the procedure shall not deviate. This plan
holds power in the effectiveness of a drug.